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Trial registered on ANZCTR


Trial ID
ACTRN12605000237684
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
26/08/2005
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II Study of AVAC (TM) for the Treatment of Atopic Dermatitis in Children
Scientific title
A blinded, randomised, placebo-controlled Phase II study to evaluate the safety and efficacy of 12.5 mcg AVAC (TM) (delipidated, deglycolipidated and arabinogalactan depleted derivative of heat-killed Mycobacterium vaccae suspension) in children with moderate-to-severe atopic dermatitis (AD)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood eczema 323 0
Condition category
Condition code
Skin 369 369 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 intradermal injections of AVAC (TM) at intervals of 2 weeks (Weeks 0, 2 and 4)
Intervention code [1] 273 0
None
Comparator / control treatment
Placebo (saline)
Control group
Placebo

Outcomes
Primary outcome [1] 430 0
Change relative to baseline in six-area, six-sign, atopic dermatitis (SASSAD) score at 3 months.
Timepoint [1] 430 0
Measured at baseline, 2 and 4 weeks, and 2, 3 and 6 months.
Secondary outcome [1] 930 0
EFFICACY: Change relative to baseline in SASSAD score
Timepoint [1] 930 0
At 6 months
Secondary outcome [2] 931 0
% AD-affected body surface area
Timepoint [2] 931 0
3 and 6 months
Secondary outcome [3] 932 0
QoL
Timepoint [3] 932 0
3 and 6 months
Secondary outcome [4] 933 0
Pruritus
Timepoint [4] 933 0
Weeks 2, 4 and at 2, 3 and 6 months
Secondary outcome [5] 934 0
Sleep disturbance
Timepoint [5] 934 0
Weeks 2,4 and at 2, 3 and 6 months
Secondary outcome [6] 935 0
Topical corticosteroid use
Timepoint [6] 935 0
Weeks 2, 4 and at 2, 3 and 6 months
Secondary outcome [7] 936 0
Total serum IgE
Timepoint [7] 936 0
3 and 6 months
Secondary outcome [8] 937 0
SAFETY: Vital signs, adverse events
Timepoint [8] 937 0
All visits
Secondary outcome [9] 938 0
Physical examination, pregnancy test
Timepoint [9] 938 0
Baseline, final visit
Secondary outcome [10] 939 0
Standard laboratory safety parameters
Timepoint [10] 939 0
Baseline, 3 months
Secondary outcome [11] 940 0
Injection site reactions
Timepoint [11] 940 0
Weeks 2, 4 and at 2, 3 and 6 months

Eligibility
Key inclusion criteria
Diagnosis of moderate-to-severe atopic dermatitis (AD). Severity defined according to Rajka and Langeland criteria; atopic dermatitis defined according to UK Atopic Dermatitis Working Party criteria.
Minimum age
5 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated block randomisation scheme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 148 0
New Zealand
State/province [1] 148 0

Funding & Sponsors
Funding source category [1] 428 0
Commercial sector/Industry
Name [1] 428 0
Genesis Reserach & development Corporation Ltd
Address [1] 428 0
1 Fox St Parnell Auckland 1001
Country [1] 428 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Genesis Research & Development Corporation Ltd
Address
1 Fox St Parnell Auckland 1001
Country
New Zealand
Secondary sponsor category [1] 346 0
None
Name [1] 346 0
None
Address [1] 346 0
Country [1] 346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1398 0
Auckland Ethics Committee Y
Ethics committee address [1] 1398 0
Ethics committee country [1] 1398 0
New Zealand
Date submitted for ethics approval [1] 1398 0
Approval date [1] 1398 0
Ethics approval number [1] 1398 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35322 0
Address 35322 0
Country 35322 0
Phone 35322 0
Fax 35322 0
Email 35322 0
Contact person for public queries
Name 9462 0
Dr Diana Gash
Address 9462 0
Genesis Research & Development Corporation Ltd
1 Fox Street
Parnell Auckland 1001
Country 9462 0
New Zealand
Phone 9462 0
+64 9 3735600
Fax 9462 0
+64 9 3732189
Email 9462 0
d.gash@genesis.co.nz
Contact person for scientific queries
Name 390 0
Dr Diana Gash
Address 390 0
Genesis Research & Development Corporation Ltd
1 Fox Street
Parnell Auckland 1001
Country 390 0
New Zealand
Phone 390 0
+64 9 3735600
Fax 390 0
+64 9 3732189
Email 390 0
d.gash@genesis.co.nz